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CT-Guided CI Programming for Hearing Loss

N/A

Waitlist Available

Led By Charles J Limb, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be willing to use the CI full-time (during waking hours) for 13 months post-activation

Is able to speak and read American English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)

Awards & highlights

Study Summary

This trial is testing whether using CT image-based frequency maps to map cochlear implants will improve user performance in speech and music perception.

Who is the study for?

This trial is for individuals with hearing loss who primarily use oral/aural communication, can attend multiple research appointments over 13 months, and are willing to wear a MED-EL cochlear implant full-time. They must be fluent in American English and have not yet activated their CI. People with atypical cochlear anatomy, electrode issues, cognitive impairments affecting test performance or pregnant women cannot participate.Check my eligibility

What is being tested?

The study tests if using high-resolution CT scans to map the placement of cochlear implant electrodes improves speech and music perception. Participants will receive custom programming based on these CT images from the first day of activation and their performance will be compared to standard settings after one year.See study design

What are the potential side effects?

While the document does not specify side effects related to this intervention directly, generally speaking, risks may include exposure to radiation from CT imaging and potential discomfort or complications associated with wearing the cochlear implant as per individual experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to use the CI device all day for 13 months after it's turned on.

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I can speak and read American English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover)

Trial Design

1Treatment groups

Experimental Treatment

Group I: CT-Based Program for First Year of CI UseExperimental Treatment1 Intervention

The Flat Panel CT scan will take place after a CI has been implanted and prior to the CI device activation. The CI device will be activated using a CT-based program. The participant may continue to use this program for 1 year. Speech and music perception abilities will be monitored at regular intervals (approx. at 1, 3, 6, and 12 months post-activation). After the 1 year of experimental program use, the participant may be switched over to a program that uses only the clinical default settings for 1 month; after which the participant will again complete the speech and music test battery. At the end of the 13 month study the participant may choose whether to use the CT-based program or the clinical default program moving forward.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,503 Previous Clinical Trials

15,236,636 Total Patients Enrolled

4 Trials studying Hearing Loss

28,365 Patients Enrolled for Hearing Loss

Charles J Limb, MDPrincipal InvestigatorUniversity of California, San Francisco

Melanie L Gilbert, AuDStudy DirectorUniversity of California, San Francisco

Media Library

CT Guided Cochlear Implant Programming (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04506424 — N/A

Hearing Loss Clinical Trial 2023: CT Guided Cochlear Implant Programming Highlights & Side Effects. Trial Name: NCT04506424 — N/A

CT Guided Cochlear Implant Programming (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506424 — N/A

Hearing Loss Research Study Groups: CT-Based Program for First Year of CI Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being taken in for this trial?

"Indeed, clinicaltrials.gov shows that this trial is still actively recruiting participants to join in. This study was initially published on September 1st 2021 and recently updated on October 4th 2022. Approximately 20 individuals are needed for the single-site investigation."

Answered by AI

Are enrollments still available for this research project?

"Clinicaltrials.gov records indicate that this medical trial is recruiting participants; the initial advertisement was broadcasted on September 1st 2021 and its details have been most recently revised on October 4th 2022."

Answered by AI